MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-03-04 for HENRY SCHEIN ONE STEP + HCG DIPSTICK FHC-101-KHS25 manufactured by Innovacon, Inc..
[784177]
In early 2008, a patient came in for breast augmentation. Urinalysis and urine hcg were done. The urine hcg result was negative. This patient called the office two days later to report her status after surgery and she stated she was pregnant. (the office doesn't know how this was determined, by a home pregnancy test or if another doctor's office did testing). Lauren mentions the fact that when this patient was seen in their office on the same day, she was either on her period (light period) or was "spotting" because she had recently (exact date unknown) had an iud put in by another doctor's office. The patient indicated in writing that she was not pregnant because she was having her mense on the same day, verified by urine analysis and she was fitted with iud.
Patient Sequence No: 1, Text Type: D, B5
[7951265]
Retention device testing performed. The retention devices meet qc specification. Correct positive results were observed when tested with 25 miu/ml hcg urine control. The 100 miu/ml, 10 iu/ml and 213. 2 iu/ml hcg urine control yielded clearly positive results at 3 minutes reading time. Probable root cause: the urine hcg level always lower than serum as the urine sample is more likely influenced by many factors. If the patient drinks too much water which will dilute the urine before the test, the urine may not contain representative levels of hcg and a false negative result may be obtained. As so, if pregnancy is suspected, a first morning urine specimen should be collected and tested. Conclusion: this complaint is not confirmed. Manufacturing documentation for this lot number was reviewed. No abnormality had been observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005689981-2008-00009 |
| MDR Report Key | 1006622 |
| Report Source | 05,08 |
| Date Received | 2008-03-04 |
| Date of Report | 2008-02-29 |
| Date of Event | 2008-01-11 |
| Date Mfgr Received | 2008-02-07 |
| Date Added to Maude | 2008-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4106 SORRENTO VALLEY BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582008910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN ONE STEP + HCG DIPSTICK |
| Generic Name | ONE STEP PREGNANCY TEST (URINE) |
| Product Code | JHJ |
| Date Received | 2008-03-04 |
| Model Number | FHC-101-KHS25 |
| Lot Number | HCG7090098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005398 |
| Manufacturer | INNOVACON, INC. |
| Manufacturer Address | 4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-04 |